Aortic ring and ancillary device for implanting it

ABSTRACT

Aortic ring ( 1 ) made of a flexible, suturable and biocompatible material, having a length, in the implanted state, making it possible to maintain a normal aortic ring diameter, said ring comprising, or being able to be combined with, means for holding the ring in a closed position in its site of implantation, in particular in a subvalvular plane.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/912,570, filed Aug. 6, 2004 (pending) which claims the benefit ofU.S. Provisional Application Ser. No. 60/552,199, filed Mar. 12, 2004(expired), which claims the priority of French Application No. 0309794,filed Aug. 8, 2003 (now French Patent No. 2858543), the disclosures ofwhich are hereby incorporated by reference herein.

TECHNICAL FIELD

The present invention relates to an artificial aortic ring intended toreduce or contain the normal aortic ring in a number of diseases of thecardiac valves. The invention also relates to ancillary devices andmethods for implanting this ring.

BACKGROUND

The natural aortic ring is a fibromuscular structure which is able toexpand in each cardiac cycle. It has a sigmoid shape made up of threecommissural summits and three nadirs corresponding to the point ofinsertion of the aortic valvules.

Insufficiency of the aortic valvules generally requires reparativesurgery. This is particularly so in the case of dystrophic valvularinsufficiency, for example annuloaortic ectasia, isolated valvulardysplasia, or bicuspid aortic valve disease.

SUMMARY

The present invention proposes to reduce or contain, when necessary, thediameter of the aortic ring, in a subvalvular and/or supravalvularposition, especially in the case of dystrophic aortic valveinsufficiency, or in the case of aortic valve replacement by means of avalve with no reinforcement, making it necessary to contain the ring ina subvalvular and/or supravalvular position.

Among these valve insufficiencies, a distinction will be made betweenthose involving lesions of the valvules, in particular acute articularrheumatism, endocarditis, and traumatic tears, and those withoutvalvular lesion and with bicuspid or tricuspid valves which aremacroscopically normal, especially annuloaortic ectasia, isolatedvalvular dysplasia, bicuspid aortic valve disease, and Laubry-Pezzisyndrome.

The subject of the invention is an aortic ring made of a flexible,suturable and biocompatible material, sterile or sterilizable, having aheight preferably at least equal to 2 mm and having a length, in theimplanted state, making it possible to maintain a normal aortic ringdiameter, said ring comprising, or being able to be combined with, meansfor holding the ring in a closed position in its site of implantation.

The dimensions of the ring are advantageously such that the ring can beimplanted around the aortic root, and in a subvalvular position.

The height of the ring according to the invention is advantageouslygreater than 1 mm and preferably between 2 and 4 mm. The choice ofheight of the ring can of course be tailored to the size and physiologyof the patient.

The ring can comprise closure means.

Thus, in a particular embodiment, it can be made from the outset in aclosed ring shape, in cases in particular where the surgicalintervention involves complete resection of an aortic segment,permitting placement of a ring that is initially closed.

In another embodiment, these means can comprise means of closure or offastening which are already in place, allowing a ring which is initiallyopen to be formed into a circle and closed at both ends. These means canbe staples or threads, for example, initially engaged in the ring, orany other means of closure.

Finally, the ring according to the invention can also be in the openform of a band which initially has no means of closure, this closurebeing able to be achieved, for example, by suturing.

In the case of a ring which is initially closed, it is advantageous toprovide sets of rings of different heights and different diameters.However, it is also possible to conceive of having just one height withdifferent diameters and of allowing the surgeon to reduce the height tothe desired value by cutting the circular ring.

In the case of a ring which is initially open, the ring isadvantageously in the form of a band whose two ends will be able to bejoined together after placement around the aortic segment to be reducedor contained. In this case too, it is possible to provide either a setof bands of different heights and/or lengths, or a ring which in theband state has a maximum length, and the ends of the ring which protrudeafter closure can be eliminated by cutting either before or afterimplantation.

The ring according to the invention is made of a flexible, suturable andbiocompatible material. This material, which must obviously be sterile,is preferably produced in a textile form permitting straightforwardfixation by suturing and/or closure of the ring, for example by athread. The material used is preferably polytetrafluoroethylene, forexample in woven form, although other biocompatible materials can beused, such as, for example, Dacron. The person skilled in the artpresently uses vascular prostheses made of Dacron or ofpolytetrafluoroethylene, and these materials are well known to him.

In a refined embodiment, the material can be elastic so as to exert apressure which makes it possible to reduce the aortic diameter in thediastolic phase, respecting the physiology of the normal aortic ring,while expanding for an increase in systolic diameter. In this case, thevariation in diameter is preferably limited to a less than 10% increasein diameter of the prosthetic ring for a pressure greater than 140 mmHg.For expandable rings, use will be made of, for example,polytetrafluoroethylene or silicone.

Preferably, the ring according to the invention can exist in three sizesdefined by the diameter of the ring. A first size is advantageously ofthe order of 23 mm, the second of the order of 25 mm, and the last ofthe order of 27 mm.

In the case of an expandable ring, the increase in diameter in each ofthese cases is preferably limited to a maximum of 2 mm.

The cross section of the ring can be analogous to that of the cut of afabric having a thickness for example of between 2 and 4 mm. However,any other shape of cross section can be provided, for example oval orothers, formed for example by knitting.

The invention also relates to the use of a ring made of a flexible,suturable and compatible material, having a height preferably at leastequal to 2 mm and preferably of between 2 and 4 mm, initially open orclosed, for production of an aortic ring, said aortic ring having inparticular the characteristics listed above, and said aortic ringcomprising or being combined with means for holding the ring in a closedposition in its site of implantation, in particular in a subvalvularposition or possibly also in a supravalvular position.

The invention also relates to an ancillary device for implanting anaortic ring according to the invention and comprising an annular frameor open arc optionally connected, preferably in a detachable manner, toa rod which is substantially transversal with respect to the plane ofthe ring or of the arc, means being provided to hold the aortic ringaccording to the invention along this frame or arc in a position whichis such that, when suturing the aortic ring around the aorta, the aorticring cannot locally fold or pucker during suturing. An ancillary devicehaving the shape of an open arc can be used when the aortic ringaccording to the invention is implanted in a subvalvular positionwithout separation of the coronary vessels.

The means for fixing the aortic ring on the ancillary device can be ofdifferent types, for example a system of foldable tabs or other fixingmeans holding the aortic ring against the frame. Alternatively, thisfixing can be effected by one or more threads connected to the frame andholding the aortic ring along this frame without any possibility ofpuckering or folding, such a thread being able to be releasedsubsequently, for example by sectioning.

The invention also relates to a method of implanting an aortic ringaccording to the invention.

This method involves positioning the ring around and outside the naturalor artificial aortic wall.

According to a first mode of implementation, the method involvesperforming an aortic subvalvular annuloplasty by placing and implantingthe ring in a circular plane below the nadir of each sigmoid valve. Thering is preferably fixed by U-shaped stitches, for example five to sixuniformly spaced stitches, which are passed from the inside outward.

For example, in the case of an aneurysm of the aortic root, the methodconsists in replacing the aortic root with a tubular implant, forexample of Dacron, indented with three Valsalva neo-sinuses, combinedwith aortic subvalvular annuloplasty round the subvalvular base of thereconstituted wall, before reinsertion of the coronary vessels.

In a second mode of implementation, which moreover can be combined withthe first one, the method involves performing supravalvularannuloplasty, at the level of the sinotubular junction by implantationof the ring, preferably using commissural U-shaped stitches passed fromthe inside outward, for example three stitches.

For example, particularly in cases of isolated valvular dysplasiawithout aneurysm of the aortic root, subvalvular annuloplasty andsupravalvular annuloplasty are performed, conserving the native aorticroot, the two rings being disposed at the two aforementioned locations.

Other advantages and characteristics of the invention will become clearon reading the following description based on a nonlimiting example andwith reference to the attached drawing, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a diagrammatic view of a closed ring according to theinvention,

FIG. 2 shows a diagrammatic view of a ring which is initially open,

FIGS. 3 through 7 show diagrammatic views of different steps inimplanting an aortic ring according to the invention in a procedureinvolving supravalvular conservation combined with subvalvularannuloplasty,

FIG. 8 shows a view of the result after longitudinal opening of theaortic root to permit better understanding,

FIG. 9 shows a photographic view at the stage in FIG. 7, showing thedetailed implantation of the ring,

FIG. 10 shows a diagrammatic view during surgery in the context ofsupravalvular and subvalvular aortic annuloplasty, with conservation ofthe native aortic root,

FIG. 11 shows a view at the same stage after longitudinal opening of theaortic root to permit better understanding,

FIG. 12 shows a view similar to that in FIG. 11, but after resection ofthe native Valsalva sinuses,

FIG. 13 shows a diagrammatic view of a first ancillary device forimplanting the aortic ring,

FIG. 14 shows a view of a modified ancillary device.

DETAILED DESCRIPTION

Reference is first made to FIG. 1.

FIG. 1 shows a ring made of Dacron (trademark), this ring 1 being madeof flexible Dacron in the form of an impermeable knit which is usual invascular surgery.

In the circular state, this ring has a diameter of 23, 25 or 27 mmdepending on the size of the ring. The height of the ring is 2 mm.

This ring can be fitted in place after total resection, permittingseparation of the aorta, for engagement around the remaining segment.

FIG. 2 shows a ring which is initially open and in the form of a band 2made of the same material as in FIG. 1, and having a length equivalentto the perimeter of the circle corresponding to the desired diameter. Byway of example, this ring has two threads 3, 4 passed through it andemerging at both ends in order to permit closure by a knot.

This closure device can be replaced by any other closure device which isstrong and biocompatible, for example clips or fasteners.

The band can also be without a thread and can then be closed using knotsof non-absorbable suture thread or the like.

The length of the band can be .pi.D, D being the diameter, for exampleone of the aforementioned diameters.

The band can also be of greater length, particularly in the case whereit does not have ready fastening means, so as to allow it to be cut tothe length desired by the surgeon.

Reference is now made to FIGS. 3 through 9 which show a ring beingimplanted in an operation involving supravalvular aortic conservationand subvalvular annuloplasty.

FIG. 3 shows the native root 10 of the aorta after resection of thethree Valsalva sinuses, revealing the three sigmoid valves 11. Thecoronary vessels 12 have been detached. Six U-shaped threads 13 havebeen placed in a circular plane below the nadir of the sigmoid valves11, these six threads being in standby to receive the aortic ring.

As will be seen in FIG. 4, a prosthesis 14 is then presented forreplacement of the ascending aorta, said prosthesis being made of Dacronand indented to form three Valsalva neo-sinuses 15.

In FIG. 5, the prosthesis 14 has been implanted and sutured.

In FIG. 6, the surgeon has now engaged, and lowered onto the ascendingaortic prosthesis 14, an initially closed aortic ring 1 which is thensecured around the aortic root, at the location marked by the threads 13which are passed through the ring 1, drawn and tightened to form knots15.

FIG. 7 shows the result once the operation has been completed. Thecoronary vessels 12 have been reinserted at two of the competentneo-sinuses 15, and the continuity of the aorta has been re-establishedat the upper end of the prosthesis 14.

FIG. 9 illustrates the end of the phase of descent of the aortic ringand its fixation, then reinsertion of the coronary vessels.

An anatomical view has been shown in FIG. 8, illustrating the positionof the aortic ring 1 situated in a plane corresponding to the root ofthe aorta and below the nadir of the sigmoids.

By virtue of the invention, it has thus been possible, by means of thesubvalvular annuloplasty achieved by the aortic ring 1, to strengthenthe aortic root and maintain its diameter during the diastolic phase.The valve function has thus been re-established without any interventionof the valves themselves.

Referring to FIG. 10, this shows the position occupied by rings, namelya subvalvular ring 2 and a supravalvular ring 1 in the case of valverepair with conservation of the native aortic root, or in the case of avalve replacement without reinforcement.

The subvalvular position of the ring 2 corresponds substantially to theposition shown in FIGS. 4 and 5. Only the implantation technique varies.This is a ring which is initially open and is passed under the coronaryostia without these being detached from the native aortic root.

The supravalvular ring 1 surrounds the three sites of commissuralimplantation of the sigmoid valves.

In practice, the two rings can be placed on aorta ends and/or implantscompleting the aorta and restoring the sinuses.

FIG. 12 shows an anatomical view of these implantations, with resectionof the native Valsalva sinuses.

Referring to FIG. 13, this shows an ancillary device 20 intended tofacilitate the implantation and suturing of an aortic ring 1 so as toavoid the risks of malpositioning and folding of the ring. Thisancillary device 20 comprises a rigid or semi-rigid frame 21 havingsubstantially the diameter of the aortic ring 1 and being fixed to theend of a handle 22, preferably via a removable fixing means 23. The ring1 is positioned under the annular part 21 and is held against the latterby foldable tabs 24 spaced at regular intervals.

The surgeon takes the assembly consisting of ancillary device and ringand lowers it to the desired position, for example the subvalvularposition shown in FIG. 7 or the supravalvular position shown in FIG. 10.Once the assembly is in place, he releases the handle 22 and the fixingdevice 23 then proceeds to suture the ring 1 in position, said ringbeing prevented from moving or folding by virtue of the presence of theannular frame 21. At the end of implantation of the ring, the surgeondeploys the arms 24 and withdraws the frame.

FIG. 14 shows another embodiment of an ancillary device, this timecomprising a rigid or semi-rigid frame in the form of an open arc 25,which is preferably deformable. A ring 2, which is initially open, isfixed in place under the arc 25 by means of foldable arms 24 or anyother fixing means, for example with the aid of threads that have beendrawn tight. The assembly formed by the intially open ring and the frame25 is mounted around the aortic root by passing the frame 25 with itsring, by rotation, under the coronary vessels, without detachment ofthese. After suturing of the ring, then release of the arc 25, thelatter can be disenagaged from the coronary vessels, by reverserotation, and withdrawn.

1. A method for surgical repair of an aortic valve of a patient, theaortic valve being exposed to alternating diastolic and systolic phasesof a cardiac cycle, the aortic valve having a valve axis and containedwithin a generally tubular aortic root with an inner surface and anouter surface, the aortic valve including a plurality of valve leaflets,the valve leaflets attached to a sigmoid-shaped valve annulus and eachhaving a leaflet free margin, the sigmoid-shaped valve annulus extendingcircumferentially around the valve axis, the sigmoid-shaped valveannulus extending in height along the valve axis between a nadir portionat a base of the aortic root and a spaced away commissure portiongenerally at a sinotubular junction of the aortic root, the aortic rootalso having a subvalvular region located generally below the nadirportion and a supravalvular region located generally above thecommissure portion, the aortic root having coronary arteries attachedthereto between the subvalvular and supravalvular regions, the aorticroot and the valve annulus expanding outwardly away from the valve axisduring a cardiac cycle transition from the diastolic phase to thesystolic phase and retracting inwardly toward said valve axis during atransition from the systolic phase to the diastolic phase, the valveleaflets movable between a closed configuration in which the leafletfree margins are in an approximated spatial relationship during thediastolic phase and an open configuration in which the leaflet freemargins are spaced away from one another during the systolic phase toallow blood flow through the aortic valve generally along a directionparallel to the valve axis, the method comprising: implanting an aorticring externally on the outer surface and around the aortic root to forma closed-perimeter flexible structure therearound; and constraining theaortic root with the closed-perimeter structure to an anatomicallyrepresentative geometry that improves coaptation of the leaflet freemargins in the diastolic phase of the cardiac cycle.
 2. The method ofclaim 1, wherein the aortic ring is elastic and expandable, and themethod further comprises: allowing the elastic aortic ring to movebetween a first ring configuration in which the aortic root is exposedto the diastolic phase and a second ring configuration of larger annularperimeter than the first ring configuration in which the aortic root isexposed to the systolic phase, whereby in the second ring configurationthe aortic ring improves the blood flow through the aortic valve byallowing a controlled expansion of the aortic root as the leaflet freemargins move apart during the systolic phase.
 3. The method of claim 1,further comprising: placing the aortic ring at the subvalvular regionexternally around the aortic root, generally adjacent the nadir portionof the valve annulus and below the attachment points of the coronaryarteries.
 4. The method of claim 3, wherein the aortic ring isconfigured as a continuous ring, and implanting the aortic ring furthercomprises: detaching the coronary arteries from the aortic root, andreattaching the coronary arteries to the aortic root above said aorticring after the aortic ring is implanted externally around the aorticroot at the subvalvular region.
 5. The method of claim 4, whereinimplanting the aortic ring further comprises: resecting aortic roottissue located between the subvalvular and supravalvular regions;implanting a vascular prosthesis above the sigmoid shaped aortic annulusto replace the resected aortic root tissue; and reattaching the coronaryarteries to said vascular prosthesis above said aortic ring.
 6. Themethod of claim 3, wherein the aortic ring is configured as an elongateelastic band having a first end and a second end and a ring closurestructure, the ring closure structure operative to join said first andsecond ends to form the closed-perimeter structure, and implanting theaortic ring further comprises: inserting the band below the attachmentpoints of the coronary arteries; and joining the first and second bandends with the ring closure structure to form the closed perimeterstructure positioned externally around aortic root at the subvalvularregion.
 7. The method of claim 1, further comprising: implanting theaortic ring at the supravalvular region externally around the aorticroot, generally adjacent the commissure portion of the valve annulus andabove the attachment points of the coronary arteries.
 8. The method ofclaim 1, wherein implanting an aortic ring further comprises: placing aplurality of U-stitches through the aortic root to secure the aorticring in position externally around the aortic root.
 9. The method ofclaim 6, wherein implanting the aortic ring further comprises: placingU-stitches through the aortic root in the subvalvular region of theaortic root to secure the aortic ring in position externally around theaortic root.
 10. The method of claim 7, wherein implanting an aorticring further comprises: placing of U-stitches through the aortic root inthe supravalvular region of the aortic root to secure the aortic ring inposition externally around the aortic root.
 11. The method of claim 8,wherein the aortic ring is configured as a continuous ring and theU-stitches are placed in the subvalvular region of the aortic root. 12.The method of claim 4, wherein implanting the aortic ring furthercomprises: evaluating the native aortic root geometry and selecting apredetermined size of the continuous ring based on native aortic rootdimensions.
 13. The method of claim 6, wherein implanting the aorticring further comprises: evaluating the native aortic root geometry andselecting a predetermined length of the elongate elastic band based onthe native aortic root dimensions.
 14. The method of claim 6, whereinthe closure structure further comprises a suture and the method furthercomprises: suturing the first and second ends of said band together withthe suture to provide the closed-perimeter structure.
 15. The method ofclaim 6, wherein the closure structure further comprises a flexible wiremember on the first and second ends of the band and the method furthercomprises: attaching the flexible wire members together to provide theclosed-perimeter structure.
 16. The method of claim 6, wherein theclosure structure further comprises a stapling member and the methodfurther comprises: stapling the first and second ends of the bandtogether with the stapling member to provide the closed-perimeterstructure.
 17. The method of claim 2, wherein the aortic ring includes asilicone member that provides the elasticity to the aortic ring.
 18. Themethod of claim 2, wherein the aortic ring includes a PTFE member thatprovides elasticity to the aortic ring.
 19. The method of claim 1,wherein the aortic ring further comprises a textile element and themethod further comprises: suturing the aortic ring to the aortic rootthrough the textile element.
 20. The method of claim 1, wherein theaortic ring undergoes an expansion of about 10% when moving from thefirst ring configuration to the second ring configuration.
 21. Themethod of claim 1, further comprising: compliantly guiding the aorticring around the aortic root, below the attachment points of the coronaryarteries.
 22. The method of claim 1, wherein the aortic ring is sizedwith a ring height ranging between 2-4 mm, and a ring perimeter lengthranging between 25-33 mm.
 23. A method for surgical repair of an aorticvalve of a patient, the aortic valve being exposed to alternatingdiastolic and systolic phases of a cardiac cycle, the aortic valvehaving a valve axis and contained within a generally tubular aortic rootwith an inner surface and an outer surface, the aortic valve including aplurality of valve leaflets, the valve leaflets attached to asigmoid-shaped valve annulus and each having a leaflet free margin, thesigmoid-shaped valve annulus extending circumferentially around thevalve axis, the sigmoid-shaped valve annulus extending in height alongthe valve axis between a nadir portion at a base of the aortic root anda spaced away commissure portion generally at a sinotubular junction ofthe aortic root, the aortic root also having a subvalvular regionlocated generally below the nadir portion and a supravalvular regionlocated generally above the commissure portion, the aortic root havingcoronary arteries attached thereto between the subvalvular andsupravalvular regions, the aortic root and the valve annulus expandingoutwardly away from the valve axis during a cardiac cycle transitionfrom the diastolic phase to the systolic phase and retracting inwardlytoward said valve axis during a transition from the systolic phase tothe diastolic phase, the valve leaflets movable between a closedconfiguration in which the leaflet free margins are in an approximatedspatial relationship during the diastolic phase and an openconfiguration in which the leaflet free margins are spaced away from oneanother during the systolic phase to allow blood flow through the aorticvalve generally along a direction parallel to the valve axis, the methodcomprising: detaching the coronary arteries from the aortic root;resecting aortic root tissue above the sigmoid-shaped valve annulus;implanting a vascular prosthesis having a terminal end indented to formValsalva neo-sinuses by suturing the terminal end to the aortic rootadjacent the sigmoid-shaped valve annulus; implanting an aortic ringexternally on the outer surface and around the aortic root to form aclosed-perimeter flexible structure therearound; reattaching thecoronary arteries to the Valsalva neo-sinuses of the vascular prosthesisat locations above the aortic ring; and constraining the aortic rootwith the closed-perimeter structure to an anatomically representativegeometry that improves coaptation of the leaflet free margins in thediastolic phase of the cardiac cycle.
 24. The method of claim 23,wherein the aortic ring is elastic and expandable, and the methodfurther comprises: allowing the elastic aortic ring to move between afirst ring configuration in which the aortic root is exposed to thediastolic phase and a second ring configuration of larger annularperimeter than the first ring configuration in which the aortic root isexposed to the systolic phase, whereby in the second ring configurationthe aortic ring improves the blood flow through the aortic valve byallowing a controlled expansion of the aortic root as the leaflet freemargins move apart during the systolic phase.